Back to results

Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression

Primary Purpose

Head and Neck Lymphedema

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FT-CC and Swallow Exercises

Swallow Exercises

About this trial

This is an interventional treatment trial for Head and Neck Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
A previous diagnosis of oropharyngeal carcinoma requiring treatment with radiation therapy
Diagnosis/evidence of lymphedema stage 1a or higher by clinical presentation based upon MD Anderson Cancer Center Head and Neck Lymphedema rating scale
EAT-10 score >4 at Baseline and Randomization Visits (prior to randomizing subject)
The head and neck garments must fit appropriately (for patients with a tracheostomy, the fit will be assessed to ensure that the garments do not interfere with their tracheostomy)
Ability to perform swallow exercises
Willing and able to comply with the study protocol requirements and all study-related visit requirements
Willing and able to provide informed consent prior to study participation

Exclusion Criteria:

Synchronous treatment for cancer (may or may not have successfully complete prior cancer treatment)
Other known causes of dysphagia such as previous radiation to the head and neck, or neuromuscular or neurodegenerative known to have a strong association with dysphagia (i.e., Parkinsons, ALS, MS, OPMD)
Poorly controlled: kidney disease (glomerular filtration rate < 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism or parathyroidism, cyclic edema, or Munchausen Syndrome (for which endocrinologist recommends against neck compression)
Carotid sinus hypersensitivity syndrome
Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
Symptomatic bradycardia in the absence of a pacemaker
Internal jugular venous thrombosis (within 3 months)
Increased intracranial pressure or other contraindications to internal or external jugular venous compression
Acute radiation dermatitis, unhealed surgical scar, unhealed or open wounds, surgical flap less than 6-8 weeks post-operative
Facial or head and neck dermal metastasis
Acute infection/inflammatory disease of the head and neck region (e.g., facial infection, parotid gland abscess, acute cellulitis, or other uncontrolled skin/untreated head and neck inflammatory skin disease)
Any condition in which increased venous and lymphatic return is undesirable
Heart failure (acute pulmonary edema, decompensated acute heart failure)
Subject is pregnant or trying to become pregnant
Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 1½ months
Any subject who is considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity)
The subject has participated in any investigational drug or device research study within 30 days of enrollment

Sites / Locations

University of California - Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FT-CC and Swallow Exercises

Swallow Exercises

Arm Description

Outcomes

Primary Outcome Measures

Swallow outcomes via modified barium swallow - Penetration-Aspiration Scale (PAS)

PAS is an eight-point ordinal severity scale scoring the depth of airway invasion by the bolus, whether it is expelled from the airway as well as any patient reaction. It ranges from one (material does not enter the airway) to eight (material enters the airway, passes below the vocal folds, and no effort is made to eject). Min value = 1, Max value = 8, the lower the score the better.

Swallow outcomes via modified barium swallow - Pharyngeal Constriction Ratio (PCR)

PCR is calculated by dividing the pharyngeal area (cm2) of the bolus hold frame (PAHOLD) by the maximum pharyngeal contraction frames (PAMAX). Min value = 0, Max value = 1. The lower the score, the better the outcome.

Swallow outcomes via modified barium swallow - Upper Esophageal Sphincter Opening (UESmax)

UES measurements will include the: (1) maximum width of the UES opening as defined by the line between the anterior and posterior walls of the pharyngoesophageal segment at its narrowest area during its maximum opening in a lateral view, and (2) the maximum width of the UES opening as viewed anteriorly. Min value = 0, max value = 2. Greater the score, the better the outcome.

Swallow outcomes via modified barium swallow - Esophageal Bolus Transit Time (ETT)

The time it takes the bolus to get through the cricopharyngeal muscle (where the esophageal phase is initiated) to the bottom of the esophagus (at the junction of the lower esophageal sphincter). Min value = 0, max value = 60. The lower the score, the better the outcome (seconds).

Swallow outcomes via modified barium swallow - Normalized residue ratio scale (NRRS)

Pharyngeal residue is the term used to describe material that remains in the pharynx post swallow (also called retention or stasis). The NRRS is calculated using ImageJ pixel area measures of residue in the valleculae. Min value = 0, max value = 1. The lower the score, the better the outcomes.

Swallow outcomes via modified barium swallow - Posterior Pharyngeal Wall Thickness (PPW)

PPW is the thickness of the posterior pharyngeal wall in lateral view while holding a 1-ml liquid bolus in oral cavity prior to swallow (PPWhold). Min value = 0, max value = 30. The lower the score the better the outcomes (mm)

Function - Stimulated Saliva Secretion Rate

Stimulated Saliva Secretion Rate is the measure of total saliva collected in 3 minutes while chewing gum.

Swallow outcomes via patient reported outcome measure - Eating Assessment Tool (EAT-10) Questionnaire Score

Min value = 0, max value = 4. The lower the score the better the outcome.

Patient Reported Function - Voice Handicap Index (VHI-10)

A survey that quantifies the functional, physical, and emotional impacts of a voice disorder on a subject's quality of life. It captures the subject's subjective rating of a series of 10 questions. Min value = 0, max value = 40. The lower the score the better the outcomes.

Patient Reported Function - Functional Assessment of Cancer Therapy - Head and Neck (FACT HN)

A survey which inquires on a series of concerns related to the head and neck region including oral comfort, breathing, voice, eating, appearance, tobacco, alcohol, and communication. The subject is asked to indicate how important each of the 39 listed concerns have been in the past 7 days. Min value = 0, max value = 148. The higher the score the better the quality of life.

Nutrition - Weight

Weight

Nutrition - Body Mass Index (BMI)

BMI

Complications - Treatment Interruptions

Number/days of treatment interruptions

Complications - Hospitalizations

Number/days of hospitalizations

Complications - Pulmonary Infections

Number/days of pulmonary infections

Complications - Adverse Events

Total number of adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT04335981

First Posted

March 10, 2020

Last Updated

November 14, 2022

Sponsor

Tactile Medical

1. Study Identification

Unique Protocol Identification Number

NCT04335981

Brief Title

Determining Swallow Outcomes in Head & Neck Lymphedema Subjects Receiving Early Intervention With Pneumatic Compression

Official Title

A Randomized, Single-Center Study to Determine Swallow Outcomes in Subjects With Head and Neck Lymphedema Receiving Early Intervention With Pneumatic Compression

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Terminated

Why Stopped

Slower than anticipated enrollment.

Study Start Date

September 24, 2020 (Actual)

Primary Completion Date

October 1, 2022 (Actual)

Study Completion Date

October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tactile Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The objective of the study is to assess the effect early pneumatic compression (prior to confirming cancer-free status via PET or CT imaging) has on swallow outcomes, positron emission tomography (PET) measurements, function, and complication rate post-radiotherapy in subjects treated for oropharyngeal cancer.

Detailed Description

This is a single-center, prospective, randomized, two-arm, wait-list control study that plans to enroll a total of 24 subjects in the United States. A baseline screening will take place where all subjects who provide consent and meet the eligibility criteria following completion of radiotherapy will begin a 6 weeks regimen of in-home swallow exercises. They will then return to the clinic for final screening and randomization into one of two treatment groups: Flexitouch Plus Cellular Connectivity (FT-CC) and Swallow Exercises (Intervention) or Swallow Exercises alone (Standard Care). A total of 3 in-clinic visits and 1 phone call will be conducted over a 12-week period. The Standard Care group will be offered an optional 6 week follow-up period to use the device in-home and will be seen in the clinic for one additional follow-up Visit 2. A reading center with personnel blinded to treatment assignment will be used to interpret the MBS and PET study results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Lymphedema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FT-CC and Swallow Exercises

Arm Type

Experimental

Arm Title

Swallow Exercises

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

FT-CC and Swallow Exercises

Intervention Description

Once daily treatment with FT Plus with investigational connectivity software and standard of care swallow exercises.

Intervention Type

Other

Intervention Name(s)

Swallow Exercises

Intervention Description

Standard of care swallow exercises.

Primary Outcome Measure Information:

Title

Swallow outcomes via modified barium swallow - Penetration-Aspiration Scale (PAS)

Description

Time Frame